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Request Number:

Current Page:

Review

Trial from ANZCTR

Trial ID

ACTRN12608000407392

Trial Status:

Registered

Date Submitted:

31/05/2007

Date Registered:

19/08/2008

Retrospectively registered

Page 1

Public title

Australian and New Zealand Cluster Randomised trial of Evidence-based Guidelines for Nutrition Support in Critical Illness

Cluster randomised trial evaluating the impact on mortality of evidence based guidelines for nutritional support in critical illness

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UTN

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Trial acronym

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Page 2

Health condition(s) or problem(s) studied:

Critical illness, fasting, starvation, malnourishment21630

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Condition category:

Condition code:

Diet and nutrition

Other diet and nutrition disorders

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Reason:

2258225800

Page 3

Descriptions of intervention(s) / exposure

The study intervention involves the implementation of National-level guidelines for the provision of nutritional support in critical illness. 27 hospitals participated in this trial: 14 hospitals were randomised to the intervention group (guidelines implementation) and 13 were randomised to the control (standard care) group. The 14 intervention group hospitals received education on the content of the feeding guidelines and the 13 control hospitals received no education. Education was provided via a formal practice change strategy composed of Educational Outreach (one session, 45-60mins), Academic Detailing (as much as required), Posters, Active Reminders, Audit and Feedback and traditional in-servicing (as many sessions as required, 30-60mins per session).

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Intervention Code:

Prevention17960

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Intervention Code:

Other interventions32790

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Comparator / control treatment

In the Control / Standard Care arm of the trial, hospitals received no educational intervention and continued to practice nutritional support as determined by current local standards.

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Control group

Active

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Page 4

Primary Outcome:

Mortality31200

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Timepoint:

Hospital Discharge31200

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Primary Outcome:

Mortality46260

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Timepoint:

Hospital Discharge46260

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Primary Outcome:

Mortality46270

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Timepoint:

Hospital Discharge46270

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Secondary Outcome:

organ dysfunction, resource consumption, severity of illness52370

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Reason:

Timepoint:

during ICU stay52370

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Secondary Outcome:

Severity of illness / measures of morbidity78210

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Timepoint:

Durint ICU stay78210

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Secondary Outcome:

morbidity78220

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Timepoint:

during ICU stay78220

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Page 5

Key inclusion criteria

Adult patients expected to require ICU care for longer than 2 days.

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Minimum age

18Years

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Maximum age

Not stated

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Gender

Both males and females

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Healthy volunteers?

No

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Key exclusion criteria

1. Already tolerating an adequate oral diet; 2. Scheduled to return to oral intake within 24 hours;3. Admitted to ICU for palliative care;4. Moribund and not expected to survive 6 hours;5. Brain dead or suspected to be brain dead;6. Admitted directly to the study ICU from any other ICU.

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Page 6

Study type

Interventional

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Purpose of the study

Prevention

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Allocation to intervention

Randomised controlled trial

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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

This was a cluster randomised trial. Hospitals (not patients) were randomised to implement the guideline or remain as controls. After agreeing to participate in the study, hospitals were randomised using a centralised computer program developed in SAS.

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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)

Cluster randomised. Hospitals (not patients) were randomised to receive and implement and evidence-based guideline or to remain as control (no guideline) hospitals.

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Type of endpoint(s)

Efficacy

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Statistical Methods/Analysis

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Page 7

Phase

Phase 3 / Phase 4

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Anticipated date of first participant enrolment

1/04/2003

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Date of first participant enrolment

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Anticipated date last participant recruited/enrolled

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Actual date last participant recruited/enrolled

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Target sample size

1500

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Recruitment status

Completed

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Recruitment in Australia

Recruitment state(s)

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Recruitment outside Australia

Page 8

Funding Source:

Charities/Societies/Foundations37440

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Name:

ANZIC Foundation37440

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Address:

Level 2, 10 Ievers Terrace - CARLTON VIC 305337440

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Country:

Australia37440

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Primary Sponsor

Individual

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Name:

Dr Gordon Doig

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Address:

Northern Clinical SchoolUniversity of SydneySydney 2006

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Country:

Australia

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Secondary Sponsor:

None33580

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Name:

33580

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Address:

33580

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33580

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Page 9

Has the study received approval from at least one Ethics Committee?

Yes

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Ethics Committee name:

University of Sydney57980

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Address:

University of SydneyHuman Research Ethics Committee,Sydney, NSW 200657980

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Country:

Australia57980

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Approval Date:

26/06/200357980

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Submitted Date:

57980

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HREC:

0209-150M57980

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Brief summary

Nutritional support is accepted as a standard of care for critically ill patients although there is little agreement as to how it is best provided. Use of evidence-based guidelines has been shown to improve the effectiveness of care. The purpose of this project is to develop, promote and evaluate evidence-based clinical practice guidelines for nutritional support in the ICU in twenty-six hospitals throughout Australia and New Zealand. One half of the hospitals will be randomised to receive educational sessions based on the content of the guidelines using previously proven and accepted educational strategies. A cluster randomised trial will then evaluate the impact of these educational sessions on acceptance of the guideline and on patient outcomes.